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Clinical Food Study to Evaluate the Effect of KB195 on Gut Nitrogen Metabolism in Patients With Urea Cycle Disorders

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ClinicalTrials.gov Identifier: NCT03797131
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Kaleido Biosciences

Brief Summary:
This clinical food study aims to explore the effect of KB195, a novel mixture of oligosaccharides, on the metabolism of nitrogen by the microbiome in patients with urea cycle disorders (UCDs). This will be done using a stable isotope to assess nitrogen metabolism in the blood, urine, and stool. The study will also assess the safety and tolerability of KB195 in patients with UCDs.

Condition or disease Intervention/treatment Phase
Urea Cycle Disorders Other: KB195 (a novel mixture of oligosaccharides) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Label Pilot Study to Evaluate the Effect of KB195, a Novel Prebiotic Gluco-Oligosaccharide Mixture, in the Diet of Patients With Urea Cycle Disorders on Gut Nitrogen Metabolism
Actual Study Start Date : January 6, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2019


Arm Intervention/treatment
Experimental: KB195 Arm Other: KB195 (a novel mixture of oligosaccharides)
KB195 (a novel mixture of oligosaccharides) for oral intake for 21 days.




Primary Outcome Measures :
  1. Change in labelled (15N-nitrogen) and total nitrogen excretion in urine [ Time Frame: Baseline to Day 25 ]
    Evaluate the effect of KB195 on nitrogen metabolism in the gut of patients with UCD by analyzing the change in labelled (15N-nitrogen) and total nitrogen excretion in urine

  2. Change in labelled (15N-urea) and total urea excretion in urine [ Time Frame: Baseline to Day 25 ]
    Evaluate the effect of KB195 on nitrogen metabolism in the gut of patients with UCD by analyzing the change in labelled (15N-urea) and total urea excretion in urine

  3. Change in labelled (15N-ammonia) and total ammonia excretion in urine [ Time Frame: Baseline to Day 25 ]
    Evaluate the effect of KB195 on nitrogen metabolism in the gut of patients with UCD by analyzing the change in labelled (15N-ammonia) and total ammonia excretion in urine


Secondary Outcome Measures :
  1. Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires [ Time Frame: Baseline to Day 32 ]
    Evaluate the effect of KB195 on self-report questionnaires including the Gastrointestinal Tolerability Questionnaire, an assessment of the frequency and severity of GI symptoms, e.g., gas, abdominal pain, calculated on a scale from 0 (None/Not applicable) to a maximum score of 60 (Severe/Much more than usual) for all questions

  2. Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires [ Time Frame: Baseline to Day 32 ]
    Evaluate the effect of KB195 on self-report questionnaires including the Bristol Stool Scale, an assessment of stool consistency on a scale from 1 (separate hard lumps, like nuts, hard to pass) through 7 (watery, no solid pieces, entirely liquid).


Other Outcome Measures:
  1. Incidence of adverse events [ Time Frame: Baseline to Day 32 ]


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed UCD patient at any age ≥ 14 years
  • Parental/legal guardian permission or patient's written informed consent or assent, as applicable
  • Be willing and able to comply with study requirements

Exclusion Criteria:

  • Any medical condition unrelated to the sequelae of UCD
  • Patient has N-acetylglutamate synthase (NAGS) deficiency
  • Recent hospitalization or risk for metabolic decompensation
  • Liver transplantation
  • Systemic antibiotics, probiotics or prebiotics that do not align with study guidances
  • Change in dose or frequency of any drug or other compound to modulate GI motility
  • Contraindications or known allergy/sensitivity to the use of the study products
  • Use of an investigational drug, product or device within 30 days prior to Screening Visit, or current enrolment in another investigational drug, product, or device study
  • Considered to be at risk for noncompliance or unlikely for any reason to be able to comply with the study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797131


Contacts
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Contact: Mark Wingertzahn (617) 674-9000 info@kaleido.com

Locations
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Switzerland
University Children's Hospital Zurich Recruiting
Zürich, Switzerland, CH-8032
Contact: Johannes Häberle, MD    +41 44 266 73 42    johannes.haeberle@kispi.uzh.ch   
Sponsors and Collaborators
Kaleido Biosciences
Investigators
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Study Director: Mark Wingertzahn Kaleido Biosciences

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Responsible Party: Kaleido Biosciences
ClinicalTrials.gov Identifier: NCT03797131     History of Changes
Other Study ID Numbers: K013-118
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaleido Biosciences:
KB195
Urea Cycle Disorders
UCD
microbiome
Kaleido
ammonia
Additional relevant MeSH terms:
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Urea Cycle Disorders, Inborn
Disease
Pathologic Processes
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases